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Date: Wednesday, May 14, 2025 9:07

Release 2.60
GALLIMUNE 302 ND+IB+EDS emulsion for injection (Northern Ireland)
 
Species: Chickens
Therapeutic indication: Immunological veterinary medical products: For chickens
Active ingredient: Vaccine Antigens
Product:Gallimune 302 ND+IB+EDS
Product index: Gallimune 302 ND+IB+EDS
Poultry - meat: Zero days.
Poultry - eggs: Zero days.
Withdrawal notes: Not to be used within 2 weeks before the onset of lay and during the laying period
Incorporating:
Qualitative and quantitative composition
Each 0.3 ml dose of vaccine contains:
Active substances:
Inactivated Newcastle disease virus, Ulster 2C strain, at least.................................... 50 PD501
Inactivated infectious bronchitis virus, Mass41 strain, at least....................................... 18 HI.U
Inactivated egg drop syndrome virus (EDS76), V127 strain, at least......................... 180 HI.U
The concentrations are expressed by the antibody titre obtained during the potency test. One unit (U) corresponding to an antibody titre of 1.
HI: haemagglutination inhibiting
1 Minimum protective dose according to monograph 0870 of Ph. Eur.
Adjuvant:
Paraffin oil................................................................................................................... 170 to 186 mg
Excipients:
Qualitative composition of excipients and other constituents
Quantitative composition if that information is essential for proper administration of the veterinary medicinal product
Thiomersal
30 μg
Formaldehyde
at most 43.2 µg
Ester of fatty acids and of polyols
Ester of fatty acids and of ethoxylated polyols
Water for injections
Whitish homogeneous emulsion.
Pharmaceutical form
Please refer to "QUALITATIVE AND QUANTITATIVE COMPOSITION" section
Clinical particulars
Target species
Chickens (breeder and layer pullets).
Indications for use
Booster immunisation of breeder and layer pullets after vaccination with live vaccines against:
- Newcastle disease virus, in order to reduce egg drop linked to Newcastle disease infection,
- Infectious bronchitis virus, in order to reduce egg drop linked to Infectious bronchitis infection caused by the Mass41 strain.
Active immunisation of breeder and layer pullets in order to reduce egg drop linked to infection with egg drop syndrome virus EDS76 without priming.
Onset of immunity: 4 weeks after vaccination
Duration of immunity: one laying period.
Contraindications
None.
Special warnings
Vaccinate healthy animals only.
Special precautions for use
Special precautions for safe use in the target species:
Not applicable.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
To the user:
This veterinary medicinal product contains mineral oil. Accidental injection/self-injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given. If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package insert with you. If pain persists for more than 12 hours after medical examination, seek medical advice again.
To the physician:
This veterinary medicinal product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Chickens:
Very common
(> 1 animal / 10 animals treated):
Abnormal histology1
1 In clinical studies, lesions at the injection site linked to the oily adjuvant were observed histologically three weeks after injections in 87 % of cases, e.g. small quantities of oily residues and occasional aseptic micro-abscesses. No palpable reactions were observed.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Do not use in birds in lay and within 2 weeks before the start of the laying period.
Interaction with other medicinal products and other forms of interaction
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Administration routes and dosage
Administer one dose (0.3 ml) by intramuscular route from the age of 18 weeks and at least 4 weeks after the priming with live vaccines against Newcastle disease (strain Hitchner B1 or VG/GA) and Infectious bronchitis (strain Mass H120).
Shake well before use.
Apply usual aseptic procedures.
Do not use syringes with natural rubber or butyl elastomer pistons.
Equipment including needles and syringes must be sterile before use.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
In addition to the adverse events mentioned in paragraph “Adverse events”, transitory apathy and slight oedema at injection site may occur after the administration of a double dose of vaccine.
Withdrawal periods
Zero days.
ATCvet code: QI01AA13
Inactivated vaccine in oily adjuvant against Newcastle disease, Infectious bronchitis and egg drop syndrome (EDS76).
The vaccine stimulates active immunity of breeder and layer pullets against egg drop syndrome (EDS76) (without priming), Newcastle disease and infectious bronchitis, subsequent to priming with live vaccines against these diseases.
Pharmaceutical particulars
Major incompatibilities
Do not mix with any other veterinary medicinal product.
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 18 months.
Shelf life after first opening the immediate packaging: use immediately.
Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C).
Protect from light.
Do not freeze.
Nature and composition of immediate packaging
Nature of primary packaging elements:
- Polypropylene bottle
- Nitrile elastomer closure
- Aluminium cap
Sales presentations:
- 150-ml (500-dose) bottle.
- 150-ml (500-dose) bottle, box of 10 bottles.
- 300-ml (1 000-dose) bottle.
- 300-ml (1 000-dose) bottle, box of 10 bottles.
Not all pack sizes may be marketed.
Disposal
Medicines should not be disposed of via wastewater or household waste.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.
Marketing Authorisation Number
Vm 08327/3010
Significant changes
Legal category
Legal category: POM-V
GTIN
GTIN description:Gallimune 302 1000 dose
GTIN:03661103006824